FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical MAJOR PACK (Model NIHB0018-11) recalled for manufacturing lubricant contamination
What this means
AVID Medical's MAJOR PACK medical device kit may contain residual manufacturing lubricant that was not properly removed during production. The contamination affects a specific component (part A942216) in kit lot 1667763. Forty units were distributed across six U.S. states.
- Check if you have MAJOR PACK Model NIHB0018-11, Kit Lot 1667763
- Contact AVID Medical or your healthcare provider for instructions on replacement or safe use
- Do not use the kit until you confirm it is not affected
The agency's original wording
Hazard
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Affected count
40
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2027More AVID Medical recalls
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